Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedure (SOP)
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1 Supplier Overview of Johnson & Johnson MD&D Supplier Quality Standard Operating Procedure (SOP) Component Qualification Process for External Manufacturers and Suppliers 1
2 Purpose The purpose of the Component Qualification Process for External Manufacturers (EMs) and Suppliers (hereafter referred to as Suppliers) standard operating procedure (SOP) is to provide a consistent set of requirements for Component Qualification activities at Suppliers of J&J MD&D Operating companies. This SOP is used to ensure that there are robust and capable manufacturing processes at Suppliers of the J&J MD&D Operating Companies. Suppliers templates and formats for Component Qualification activities may be used provided they contain and comply with the minimum requirements of this SOP and are approved by the respective J&J MD&D Operating Company representative. 2
3 Scope This SOP is Applicable for: New component development Component design changes affecting a Supplier manufacturing process A Supplier process change which affects manufacturing processes used to make the component Transfer of component manufacturing processes 3
4 Responsibilities The Supplier is responsible for following the requirements in this SOP as direct by the J&J MD&D Operating Company The Supplier may develop the Component Qualification Plan, but at a minimum, it shall be in accordance with J&J MD&D Operating Company requirements. The Supplier is responsible for signing off on the plan confirming their acknowledgment The Supplier is also responsible for executing the approved Component Qualification Plan and submitting requested documentation to the J&J MD&D Operating Company 4
5 General Requirements The Component Qualification Process is divided into five phases: Phase 1: Initiation Phase 2: Planning Phase 3: Execution Phase 4: Review and Disposition Phase 5: Communication 5
6 Phase 1 Initiation The Component Qualification process is initiated for the conditions identified in the scope section of this SOP. New component development Component design changes affecting a Supplier manufacturing process A Supplier process change which affects manufacturing processes used to make the component Transfer of component manufacturing processes For all of the above, the J&J MD&D Operating Company will determine the extent of component qualification activities required 6
7 Phase 2 Planning The following actions will take place during planning: Assessment of the extent of Component Qualification activities required Identification of deliverables Creation and approval of the plan Typical items considered during planning are as follows: 1. Product requirements 2. Manufacturing Materials/Process Aids 3. Process Flow Diagram 4. Process Risk Analysis 5. Measurement System Analysis (MSA) 6. Equipment Installation Qualification (IQ) 7. Process Characterization 8. First Article Inspection (FAI) 9. Process Operational Qualification (OQ) 10. Performance Qualification (PQ) 11. Process Capability Assessment 12. Process Control Plan 13. Process Work Instructions 7
8 Phase 3 Execution The Supplier shall execute their activities as documented in the Component Qualification Plan. If a deviation from the plan is required, the Supplier will notify the J&J MD&D Operating Company to assess the impact. Deviations are to be reviewed prior to execution. 8
9 Phase 4 Review & Disposition The Supplier shall submit to the J&J MD&D Operating Company specified deliverables from the Component Qualification Plan. Suppliers are expected to utilize the Qualification Summary Report content and format as specified by the J&J MD&D Operating Company. The J&J MD&D Operating Company will determine the appropriate approval functions. 9
10 Phase 5 Communication The J&J MD&D Operating Company will notify the Supplier regarding the approval and implementation strategy, as applicable. 10
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